Kelun Pharmaceutical: Subsidiary's Injectable Aripiprazole Approved for Drug Registration

Kelun Pharmaceutical Announcement: The subsidiary Hunan Kelun Pharmaceutical Co., Ltd.'s chemical drug “Injectable Aripiprazole” has recently received drug registration approval from the National Medical Products Administration. Injectable Aripiprazole is a long-acting microcrystalline formulation administered once a month. Compared to oral medications, it can improve patient medication adherence, reduce the risk of disease relapse, lower peak-trough blood concentration fluctuations, enhance medication safety, and lighten the burden on healthcare providers, patients, and society. It is currently widely recommended by domestic and international authoritative guidelines such as the “Chinese Expert Consensus on Maintenance Treatment of Schizophrenia (2024),” the “Expert Consensus on Long-Acting Injectable Antipsychotics for Schizophrenia Treatment (2020),” and the “Pharmacological Treatment of Schizophrenia: Japanese Expert Consensus (2021).” Injectable Aripiprazole is classified as a Category B drug under the medical insurance system, with global sales estimated at approximately $2.2 billion in 2025.